What happened
Shares of Axsome Therapeutics (AXSM 0.49%), a clinical-stage biopharmaceutical company, rocketed 61.5% in April, according to data from S&P Global Market Intelligence. In addition to recovering from a coronavirus-fueled market crash in March, pivotal data from two successful studies pushed up the stock last month.
So what
March was a rough month for Axsome Therapeutics shareholders. In addition to pandemic-inspired panic selling, the stock took a beating after the company announced a late-stage mishap with its lead candidate, AXS-05.
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Investors that held on to their shares were made whole by the end of April thanks to a couple of positive data drops. The company's migraine headache candidate, AXS-07, met its main goal in a pivotal study and a new drug application for the acute pain reliever should reach the FDA in the fourth quarter.
Last month, Axsome also announced positive results from a pivotal study with AXS-05 and patients with Alzheimer's disease agitation. This is a condition marked by excessive activity and verbal aggression that makes providing their care especially challenging.
Now what
Although AXS-05 failed to meet its primary endpoint in a treatment-resistant depression study, Axsome is preparing a new drug application for the treatment of major depressive disorder (MDD) that should be ready for the FDA in the fourth quarter.
Alzheimer's affects an estimated 6 million Americans at the moment, and this figure is expected to reach 14 million by 2050. In addition to this enormous population, AXS-05 could also generate blockbuster sales as a new treatment option for MDD, a condition that an estimated 17.3 million American adults experience at least once per year.
